Mumbai: Sun Pharmaceutical Industries on 27 September said its US subsidiary has won the USFDA approval for Methimazole tablets, used for treating thyroid disorders.
The firm’s subsidiary Caraco Pharmaceutical Laboratories Ltd was granted the approval for Abbreviated New Drug Application (ANDA) for Methimazole tablets (5 mg and 10 mg) by the US Food and Drug Administration (USFDA), it said in a filing to the Bombay Stock Exchange.
Methimazole is indicated in the medical treatment of hyperthyroidism.
“We are pleased to receive this approval from the FDA. This marks the third approval in the last 30 days and the sixth approval this quarter. This is in addition to the two tentative approvals granted by the FDA during the period. This will bring our total product selection to 41 different products represented by 86 various strengths,” said chief executive officer of Caraco Pharmaceutical Daniel H Movens.
Detroit-based Caraco Pharmaceutical develops, manufactures, markets and distributes generic and private-label pharmaceuticals.
Shares of Sun Pharmaceutical were trading at Rs960, up 1.52% at the BSE.